FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Blood Specimen Convenience Kit
DI: 00859952006154
·
Model: SA95204
·
CAPITOL VIAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Blood Specimen Convenience Kit
- Primary DI
- 00859952006154
- Version / Model
- SA95204
- Catalog Number
- SA95204
- Company Name
- CAPITOL VIAL, INC.
- Labeler DUNS
- 151639481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-25
- Public Version
- 4
- Public Version Date
- 2023-08-23
- Public Version Status
- Update
- Public Device Record Key
- 08a6b679-2276-454d-a086-6ce50ed4f9f7
- Distribution End Date
- 2021-12-31
Device Description
Blood Specimen Convenience Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47591 | Evacuated blood collection tube IVD, anticoagulant/antiglycolytic | A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), ammonium oxalate, potassium oxalate, sodium heparin, sodium citrate], and an antiglycolytic agent (e.g., sodium fluoride, lithium iodoacetate). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood glucose or lactate determinations). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859952006154 | GS1 | ||||
| Package | 10859952006151 | GS1 | Carton | 48 | Not in Commercial Distribution | 2021-12-31 |
Customer Contacts
- Phone
- 1-800-772-8871
- [email protected]